Approval · Notice of Compliance 22549 · 2019
JINARC: Notice of Compliance 22549
Issued August 16, 2019
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
- Notice number
- 22549
- Date
- August 16, 2019
- Company
- Otsuka Pharmaceutical Co LtdChiyoda-Ku Tokyo, --, Japan
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Labelling Only
- Reason
- To add two new combinations (15mg + 15mg, 30mg + 15mg) to the existing product line.